Pediatric Crohn's Disease

Medication Guide

For Children and Teens With PCD

Having pediatric Crohn's disease (PCD) doesn't mean you have to miss out on all the fun of being a kid. You don't have to worry about feeling sick all the time. The important thing is to be open and honest, and to discuss how you're feeling with your parents and your doctor. They want to know how your symptoms are affecting you so they can help find the best care and treatment for you.

It can also be helpful to let other adults like your teachers and the school nurse know you have PCD. That way, they'll be prepared to support you when you're not feeling well.

Remember, you can take charge of your disease. Start by learning everything you can about PCD. You'll find valuable information at www.LivingWithCrohnsDisease.com. This Web site has a whole section on PCD, where you can find information on important topics like:

How PCD may affect your body, mood, family and friends, and schoolwork

How to talk about PCD with the people around you—friends, family members, classmates, and teachers

How to eat in a healthy way

Places to turn for further resources and support

So what is REMICADE®?

REMICADE® is a type of medicine that works by blocking a protein in your body that causes inflammation in your intestines. This inflammation causes diarrhea, stomach pain, and fever, and also makes you feel tired. Because REMICADE® helps reduce inflammation, and improves the symptoms of PCD.

How do I take REMICADE®?

Only a doctor or nurse can give you REMICADE®. That means you have to go to your doctor's office or a place called an infusion center to get it. They'll hook up an IV infusion to your arm or hand let the medicine drip in, kind of like you've seen on TV.

We know it's kind of unusual to get medicine through an IV. When medicine is infused, it goes straight into your bloodstream and gets to work. Getting an infusion may seem weird at first, but you'll have someone nearby to make sure that everything goes well.

Please read the Medication Guide for REMICADE® and talk to your parents and your doctor about it.

Infusion fashion: What should I wear?

You'll have at least 2 hours to kick back, relax, listen to the latest tunes, or even do a little schoolwork while you receive your infusion of REMICADE®. So be sure to wear comfortable clothes.

How often do I have to go for infusions?

After the 3 starter doses, you will only have to receive REMICADE® once every 8 weeks. That's about every 2 months, or as few as 6 times a year.

How long will I feel better?

Approximately 88% of children (nearly 9 out of 10) experienced symptom improvement as soon as 10 weeks after starting treatment with REMICADE®. And for most of those children, symptom relief lasted for the duration of the study—through 1 year. Talk to your parents and your doctor to see if REMICADE® is right for you.

How should I talk to my friends about PCD?

Having PCD is pretty personal, and although it's not your fault, you probably feel self-conscious about it. Discussing it can be uncomfortable, so you may have trouble talking about it even with your family and closest friends. Or maybe you want to tell everybody so you don't have to worry about keeping it a secret. Whatever decision you make should be the one that you feel most comfortable with.

Here are a few ideas that can help make it easier to tell your friends about PCD:

Think about what you want to say: Maybe you want to say that PCD is a serious condition that causes you to have stomach pain and makes you really tired. Maybe not. But figuring it out ahead of time will make it easier to talk about

Explain the symptoms: Everyone can relate to stomach pain, fevers, and fatigue. As quiet as they may keep it, most of your friends can relate to having diarrhea too, but how much you share is totally up to you

Answer questions: It'll stop your friends' imaginations from running wild, and let you know if they understand what you've been saying. The main thing they'll probably want to know is that PCD is not contagious—they can't catch it from you

Try to have a sense of humor: If you can make a joke or laugh, chances are you can make your friends feel more at ease too

Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven't responded well to other therapies

Approved for the treatment of adult patients with chronic severe (extensive and/or disabling) plaque psoriasis under the care of a physician who will determine if REMICADE® is appropriate considering other available therapies

Only your doctor can recommend a course of treatment after checking your health condition. REMICADE® (infliximab) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE®.

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking REMICADE® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE®, the chances of getting lymphoma or other cancers may increase.

You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take REMICADE®?

You should let your doctor know if you have or ever had any of the following:

Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE®.

Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

Infections that keep coming back, have diabetes or an immune system problem.

Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.

Heart failure or any heart condition. Many people with heart failure should not take REMICADE®.

Hepatitis B virus (HBV) infection or think you may be a carrier of HBV. Your doctor will test you for HBV.

Use the medicines Kineret (anakinra), Orencia (abatacept) or Actemra (tocilizumab) or other medicines called biologics used to treat the same problems as REMICADE®.

Are pregnant, plan to become pregnant, are breast-feeding, or have a baby and were using REMICADE® during your pregnancy. Tell your baby’s doctor about your REMICADE® use before the baby receives any vaccine because of an increased risk of infection for up to 6 months after your last dose of REMICADE® you received during your pregnancy.

Recently received or are scheduled to receive a vaccine. Adults and children taking REMICADE® should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer) while taking REMICADE®.

What should I watch for and talk to my doctor about before or while taking REMICADE®?

The following serious (sometimes fatal) side effects have been reported in people taking REMICADE®.

You should tell your doctor right away if you have any of the signs listed below:

Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE® can make you more likely to get an infection or make any infection that you have worse.

Lymphoma, or any other cancers in adults and children.

Skin cancer—any changes in or growths on your skin.

Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.

This site is published by Janssen Biotech, Inc. , which is solely responsible for its contents. The material on this site is intended only as informational or as an educational aid and it is not intended to be taken as medical advice. The ultimate responsibility for patient care resides with a healthcare professional.

This information is intended for the use of patients and caregivers in the United States and Puerto Rico only. Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.